Kelulut Honey for Allergic Conjunctivitis and Dry Eye Symptoms

NCT ID: NCT07273747

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2026-09-30

Brief Summary

The goal of this clinical trial is to learn if oral Kelulut honey works to improve eye symptoms in adults with allergic conjunctivitis. It will also look at how safe Kelulut honey is when taken as a daily supplement.

The main questions it aims to answer are:

1. Does oral Kelulut honey reduce itchy, red, watery eyes and dry eye symptoms in people with allergic conjunctivitis?

2. Does oral Kelulut honey improve tear film stability and the health of conjunctival goblet cells (special cells on the eye surface that help keep the eye moist)?

3. What side effects or medical problems do participants have when taking Kelulut honey?

Researchers will compare oral Kelulut honey to a honey-flavoured placebo syrup (a look-alike drink that does not contain Kelulut honey) to see if Kelulut honey is more effective than placebo for treating eye symptoms in allergic conjunctivitis.

Participants will:

1. Take either oral Kelulut honey or a honey-flavoured placebo syrup every day for 1 month

2. Continue their usual treatment for allergic conjunctivitis and dry eye disease as prescribed by their eye doctor

3. Attend clinic visits for eye check-ups, including tests of tear film stability, dry eye symptoms, and eye surface health

4. Answer questionnaires about their eye symptoms and how these affect their daily activities and vision-related quality of life

Participation is voluntary, and participants may stop taking part in the study at any time. Data collected up to the time they withdraw may still be used for research, but their routine medical care will not be affected

Conditions

Dry Eye Symptoms; Allergic Conjunctivitis of Both Eyes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Kelulut Honey 60 g (KH-60)

Kelulut honey is provided in pre-packaged 30 g sachets to standardize dosing and maintain blinding across study arms.

Group Type: EXPERIMENTAL

Kelulut Honey 60 g Oral Supplement

Intervention Type: DIETARY_SUPPLEMENT

Participants in this arm will consume two 30 g sachets of Kelulut honey once daily (total 60 g/day) for one month. The honey will be taken directly from the sachet without dilution, on an empty stomach, 30 minutes before breakfast. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.

Kelulut Honey 120 g (KH-120)

Kelulut honey is provided in pre-packaged 30 g sachets to standardize dosing and maintain blinding across study arms.

Group Type: EXPERIMENTAL

Kelulut Honey 120 g Oral Supplement

Intervention Type: DIETARY_SUPPLEMENT

Participants in this arm will consume four 30 g sachets of Kelulut honey daily (total 120 g/day) for one month. The daily dose will be divided into two administrations: two sachets before breakfast or lunch, and two sachets before dinner. The honey will be taken directly from the sachets without dilution, at least 30 minutes before meals. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.

Placebo

The placebo consists of a honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to the Kelulut honey sachets to maintain blinding.

Group Type: PLACEBO_COMPARATOR

Honey-Flavoured Zero-Calorie Syrup (Placebo)

Intervention Type: OTHER

Participants in this placebo group will receive honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to those used for the Kelulut honey. Each participant will consume two sachets per day, to be taken daily, once before breakfast, for one month duration. The syrup is to be taken directly from the sachets, without dilution, before meals.

Interventions

Kelulut Honey 60 g Oral Supplement

Participants in this arm will consume two 30 g sachets of Kelulut honey once daily (total 60 g/day) for one month. The honey will be taken directly from the sachet without dilution, on an empty stomach, 30 minutes before breakfast. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.

Intervention Type: DIETARY_SUPPLEMENT

Kelulut Honey 120 g Oral Supplement

Participants in this arm will consume four 30 g sachets of Kelulut honey daily (total 120 g/day) for one month. The daily dose will be divided into two administrations: two sachets before breakfast or lunch, and two sachets before dinner. The honey will be taken directly from the sachets without dilution, at least 30 minutes before meals. Participants will continue their usual treatment for allergic conjunctivitis and dry eye disease.

Intervention Type: DIETARY_SUPPLEMENT

Honey-Flavoured Zero-Calorie Syrup (Placebo)

Participants in this placebo group will receive honey-flavoured zero-calorie syrup, pre-packaged in sachets identical to those used for the Kelulut honey. Each participant will consume two sachets per day, to be taken daily, once before breakfast, for one month duration. The syrup is to be taken directly from the sachets, without dilution, before meals.

Intervention Type: OTHER

Other Intervention Names

KH-60; Group A; KH-120; Group B; Group C; KH-P

Eligibility Criteria

Inclusion Criteria

i. Age between 18-40 years old ii. Confirmed diagnosis of allergic conjunctivits iii. Ocular surface disease index (OSDI) score > 12 iv. Compliance to conventional allergic conjunctivitis treatment

Exclusion Criteria

i. Any corneal or ocular surface pathology ii. Known diabetes mellitus or impaired glucose test iii. Ocular surface disease due to trachoma or other inflammatory conditions iv. Consume anti-inflammatory medications such as steroids, NSAIDS, oral doxycycline v. Concurrent use of other supplements or alternative therapies such as royal jelly, Manuka honey eye drop or omega-3 fatty acid vi. Using preservative-containing topical eye drops for ocular problems other than AC, such as anti-glaucoma medication vii. History of ocular trauma/surgery or refractive surgery within last 3 years viii. Wearing contact lens in the last 3 months ix. Underlying inflammatory/ systemic disease and connective tissue diseases x. Recent conjunctivitis in the last 3 months xi. Patients on immunosuppressant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Shahidatul Adha Mohamad

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahidatul Adha Dr, MD, MMed

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Hospital Pakar Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Sharifah Izzati Dr, MD

Role: CONTACT

shzatiee@gmail.com

+6010-2329207

Other Identifiers

USM/JEPeM/KK/24080659

Identifier Type: -

Identifier Source: org_study_id